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Completed

NCT Number: NCT00137371

Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis

This protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated estrogen cream (PVC) given vaginally in postmenopausal women with atrophic vaginitis.

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Key information

Conditions

Atrophic Vaginitis Atrophy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urogenital Diseases Vaginal Diseases Vaginitis

Age range

45 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Calgary, Alberta, Canada

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Generally healthy postmenopausal women with symptoms of atrophic vaginitis including vaginal dryness, vaginal itching, vaginal burning, and/or painful intercourse.

The subject must have a clinical diagnosis of atrophic vaginitis and an intact uterus.

Exclusion criteria

Women who do not have a clinical diagnosis of atrophic vaginitis.

Treatment and study plan

PVC (daily for 21 days, 7 days off)

Drug

PVC (twice weekly)

Drug

Primary outcomes

  1. To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.

Secondary outcomes

  1. To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administered Vaginally in Postmenopausal Women With Atrophic Vaginitis

Important dates

Study start
2005
Study completion
2007
First posted
Aug 29, 2005
Registry last updated
Dec 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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